Home NDC 0591-3524 Testosterone
Product NDC 0591-3524
11-digit product format 005913524
Labeler code 0591
Product ID 0591-3524_2e95e259-83f9-4189-885b-0d119c3a3885
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Testosterone
Dosage form GEL
Route TRANSDERMAL
Labeler Actavis Pharma, Inc.
Application ANDA091073
Marketing category ANDA
Marketing start 2017-10-12
Substance TESTOSTERONE
Active strength 50 mg/5g
Pharmacologic classes Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]
DEA schedule CIII
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091073-001 TESTOSTERONE TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2017-09-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091073-001 AB2
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A091073-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2017-09-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091073-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2017-09-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091073-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2017-09-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091073-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2017-09-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091073-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2017-09-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091073-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2017-09-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091073-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2017-09-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091073-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2017-09-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091073-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2017-09-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091073-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2017-09-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091073-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2017-09-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091073-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2017-09-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091073-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2017-09-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091073-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2017-09-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091073-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2017-09-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091073-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2017-09-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091073-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2017-09-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091073-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2017-09-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091073-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2017-09-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091073-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2017-09-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091073-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2017-09-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091073-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2017-09-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091073-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2017-09-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091073-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2017-09-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091073-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2017-09-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091073-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2017-09-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091073-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2017-09-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091073-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2017-09-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091073-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2017-09-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091073-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2017-09-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091073-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2017-09-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091073-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2017-09-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091073-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2017-09-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091073-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2017-09-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091073-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2017-09-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091073-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2017-09-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091073-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2017-09-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091073-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2017-09-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091073-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2017-09-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091073-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2017-09-18 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Testosterone
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TESTOSTERONE 50 mg/5g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3XMK78S47O Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1597129 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0591-3524-26 Testosterone 5 g in 1 TUBE GEL 5 19 0591-3524-30 Testosterone 30 in 1 CARTON GEL 30 19
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0591-3524 TESTOSTERONE GEL [ACTAVIS PHARMA, INC.] 16 Current NDC, Legacy NDC, 2 package rows 20231021_e18b4495-c5a3-4a7f-9636-179320784381.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0591-3524-26 00591352426 5 g in 1 TUBE 5 g Historical 0591-3524-30 00591352430 30 TUBE in 1 CARTON (0591-3524-30) / 5 g in 1 TUBE (0591-3524-26) 30 tube 2017-10-12 0000-00-00 No No Current